How do I identify a recalled Baxter 0.9% Sodium Chloride Injection bag?

Locate the lot number on the bag’s side panel or shipping carton and compare it to the recalled lot numbers Y495523 and Y495523A.

Are other Baxter saline products safe to use?

Yes, the recall affects only the two specified lots. All other Baxter saline products remain safe when used according to labeling.

What should I do if a patient received Baxter saline from the recalled lot?

Monitor the patient for embolism, inflammation or allergic reactions and report any issues to FDA MedWatch and to Baxter.

Will Baxter replace or credit the recalled Baxter 0.9% Sodium Chloride products?

Baxter will issue credit or replacement once the affected product is returned through the established return-authorization process.

Has the FDA reported any injuries linked to the Baxter saline recall?

No injuries have been reported; the recall is preventive due to potential risk of fiberglass contamination.

How can I report quality concerns related to Baxter 0.9% Sodium Chloride Injection?

Submit a report via the FDA MedWatch online portal or request a mail/fax form by calling 1-800-332-1088.

FDA Recall: Baxter 0.9% Sodium Chloride Injection, for Potential presence of particulate matter identified as fiberglass in the solution.

Source: FDA

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FDA Recall: Baxter 0.9% Sodium Chloride Injection, for Potential presence of particulate matter identified as fiberglass in the solution.

Q: Which Baxter 0.9% Sodium Chloride Injection lots are recalled?

Lots Y495523 and Y495523A of Baxter 0.9% Sodium Chloride Injection, USP, 500 mL VIAFLEX bags are recalled.

Baxter • August 26, 2026

FDA Recall: Baxter 0.9% Sodium Chloride Injection Contaminated with Fiberglass Particles

Baxter International Inc. has announced a voluntary, nationwide recall of two lots of Baxter 0.9% Sodium Chloride Injection, USP (500 mL VIAFLEX) after routine quality testing suggested that fiberglass particles may be present in the solution. Intravenous infusion of particulate matter can cause blood-vessel obstruction, pulmonary embolism or other life-threatening events. Health-care professionals are urged to discontinue use of the affected lots immediately, quarantine remaining inventory and coordinate product returns with Baxter.

Key Recall Facts for Baxter 0.9% Sodium Chloride Injection

Recall initiated by company: August 25, 2026
FDA publication date: August 26, 2026
Product category: Prescription I.V. solution (drug)
Root cause: Potential fiberglass particulate contamination
Distribution window: July 31 – August 3, 2026
States shipped to: FL, IL, IN, LA, MD, MO, NC, NJ, NV, NY, OH, SC, TX, VA

Sources

FDA Recall Announcement

Affected Baxter Product Codes and Lot Numbers

Product Code	Lot Number	Expiration Date	NDC
2B1323Q	Y495523	31-Oct-2027	0338-0049-03
2B1323Q	Y495523A	31-Oct-2027	0338-0049-03

Health Risks of Fiberglass Particles in I.V. Fluids

If fiberglass fragments enter the bloodstream, they can:

Obstruct blood vessels and limit oxygen delivery to vital organs
Trigger a pulmonary embolism, an emergency that can be fatal
Cause local vein irritation, phlebitis or inflammatory reactions
Exacerbate existing infections or provoke allergic responses

No injuries have been reported as of this writing, but the recall is classified as Class I—the FDA’s most serious designation—because use of the product could cause serious harm.

Required Actions for Hospitals, Clinics and Distributors

Cease use of all Baxter 0.9% Sodium Chloride Injection bags from lots Y495523 and Y495523A.
Quarantine the recalled inventory to prevent accidental administration.
Arrange product return or credit by following Baxter’s emailed instructions or calling Baxter Healthcare Center for Service at 888-229-0001 (7 a.m. – 6 p.m. CT, Monday – Friday).
Report any adverse events or quality problems to the FDA MedWatch program:
- Submit a report online
- Download a paper form at MedWatch or request one by calling 1-800-332-1088

Images Included in the Baxter Recall Notice

Baxter 0.9% Sodium Chloride Injection VIAFLEX container label — Source: FDA

Baxter 0.9% Sodium Chloride Injection shipping carton label — Source: FDA

Frequently Asked Questions About the Baxter Saline Recall

1. Which Baxter 0.9% Sodium Chloride Injection lots are recalled?: Baxter lots Y495523 and Y495523A, product code 2B1323Q, expiration 31-Oct-2027.
2. How do I identify a recalled Baxter 0.9% Sodium Chloride Injection bag?: Check the lot number printed on the side panel of each VIAFLEX bag and on the outer shipping carton. Match it against the affected lot numbers above.
3. Are other Baxter saline products safe to use?: Yes. The recall is limited to the two lots listed. All other Baxter saline solutions and package sizes remain unaffected and can be used as directed.
4. What steps should I take if a patient received Baxter saline from a recalled lot?: Closely monitor the patient for symptoms of embolism (shortness of breath, chest pain), vein irritation or allergic reactions. Report any adverse outcomes to the FDA MedWatch program and to Baxter.
5. Will Baxter replace or credit the recalled Baxter 0.9% Sodium Chloride products?: Yes. Baxter will issue a credit or replacement once the recalled product is returned through the company’s established return-authorization process.
6. Has the FDA reported any injuries linked to the Baxter saline recall?: No injuries have been reported to date; the recall is a preventive measure based on potential risk.
7. How can I report quality concerns related to Baxter 0.9% Sodium Chloride Injection?: Submit a report through the FDA MedWatch online portal or call 1-800-332-1088 for a mail/fax form.